CASUS: Validation for Detection of Precursor Lesions

Cervical Cancer Clinical Trial

— CASUS-WP4  

Official title:

Developing a Complete Cervical Cancer Screening Solution Based on First-void Urine Self-sampling: Validation for Detection of Precursor Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04530201
• Other study ID #: BE3002020000101
• Status: Completed
• Phase: N/A
• Start date: August 20, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: June 2022
• Source: Universiteit Antwerpen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of the overall CASUS project is to develop the first fully molecular integrated cervical cancer screening approach, based on first-void urine as an easily accessible and non-invasive source of biomarkers. In contrast to current screening modalities, the CASUS approach will identify women with clinically relevant disease in need of treatment using only a single sample that can be collected at home (one-step triage).

Description:

CASUS work package 4 (WP4): The main aim of this study is to validate the HPV-Risk assay (Self-screen, The Netherlands) followed by multiplex methylation specific quantitative PCR (qMSP, VU University Medical Center, The Netherlands) on first-void urine (Colli-Pee Small Volumes (10 mL) device, Novosanis, Belgium) of HPV positive women for detection of clinically relevant precursor lesions by sampling a cohort of women referred for colposcopy. The number of women in this cohort will allow us to clinically validate the use of the HPV-Risk/qMSP assay in DNA extracts of first-void samples after optimization of sample volume, internal process control, and DNA extraction method (Centre for the Evaluation of Vaccination, University of Antwerp, Belgium).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: February 28, 2022
• Est. primary completion date: October 20, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 64 Years

Eligibility

Inclusion Criteria:

• Female
• 25 years until 64 years old
• Referred to colposcopy due to a single/multiple (probable) high-risk HPV infection and/or abnormal cervical squamous intraepithelial/glandular lesion.
• Gives informed consent to the research team at the clinical study site to contact his/her general practitioner and/or gynaecologist to access details of the participants HPV test results and cervical screening history.
• Is able to understand the information brochure/what the study is about.

Exclusion Criteria:

• Women that underwent hysterectomy
• Pregnant women
• Treatment for cervical cancer in the last 6 months before participation in the study
• Participating in an interventional clinical study (where e.g. a medical device, drug, or vaccine is evaluated) at the same time of participating in this study. Participation in another observational or low-interventional clinical study at the same time is allowed.

Related Conditions & MeSH terms

• Cervical Cancer
• Cervical Intraepithelial Neoplasia
• HPV-Related Cervical Carcinoma
• Human Papilloma Virus
• Papilloma
• Urine
• Uterine Cervical Neoplasms

Intervention

Device:
• Colli-Pee Small Volumes (10 mL) device
Women will self-collect two first-void urine samples at home the day prior to colposcopy using the new generation Colli-Pee Small Volumes (10 mL) device (Novosanis, Belgium). The collector tube will be prefilled with a non-toxic nucleic acid preservative including an internal process control.

Locations

Country	Name	City	State
Belgium	Vrouwenkliniek - Universitair Ziekenhuis Gent (UZ Gent)	Gent	Oost-Vlaanderen
Belgium	Gynécologie-obstétrique - CHU de Liège	Liège
Belgium	Femicare VZW & Departement Verloskunde & Gynaecologie - Regionaal Heilig Hart Ziekenhuis Tienen	Tienen	Vlaams-Brabant

Sponsors (4)

Lead Sponsor	Collaborator
Universiteit Antwerpen	Amsterdam UMC, location VUmc, Novosanis NV, Self-screen B.V.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68)) measured using the HPV-risk assay (Self-Screen BV).	Analytical test results: HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68)) concentrations [cycle threshold values] in first-void urine samples from all study participants.; Clinical test accuracy: HPV DNA (HPV16, HPV18, other high-risk HPV (HPV31, -33, -35, -39, -45, -51, -52, -56, -58, -59, -66, -67, and -68)) test outcomes [positive, negative] in first-void urine samples from all study participants compared to the gold standard reference test for cervical cancer screening; i.e. histology [Cervical Intraepithelial Neoplasia grade 0-3+].	Through study completion, an average of 1 year
Primary	Methylation ratio of a host cell gene marker panel (PreCursor-U+) measured using quantitative methylation specific PCR (qMSP).	Analytical test results: Methylation levels of a host cell gene marker panel (PreCursor-U+) reported in a methylation ratio [(2^-deltaCT *100) with CT being cycle threshold values] in first-void urine samples from all study participants.; Clinical test accuracy: Methylation panel (PreCursor-U+) test outcomes [positive, negative] in first-void urine samples from all study participants compared to the gold standard reference test for cervical cancer screening; i.e. histology [Cervical Intraepithelial Neoplasia grade 0-3+].	Through study completion, an average of 1 year
Secondary	Human DNA (GAPDH)	Human DNA (GAPDH) concentrations [cycle threshold values] in first-void urine samples from all study participants measured by quantitative PCR (qPCR).	Through study completion, an average of 1 year
Secondary	Internal control DNA (IC DNA)	Internal control DNA (IC DNA) concentrations [cycle threshold values] in first-void urine samples from all study participants measured by quantitative PCR (qPCR).	Through study completion, an average of 1 year
Secondary	Human DNA (Beta-globin)	Human DNA (Beta-globin) concentrations [cycle threshold values] in first-void urine samples from all study participants measured using the HPV-risk assay (Self-Screen BV).	Through study completion, an average of 1 year
Secondary	Human DNA reference gene (ACTB)	Human DNA reference gene (ACTB) concentrations [cycle threshold values] in first-void urine samples from all study participants measured by quantitative methylation specific PCR (qMSP).	Through study completion, an average of 1 year